Evaluating the Utility of RELiZORB™ for Treating Feeding Intolerance in Critically Ill Adults With Multi-Organ Failure

Part of paid clinical trials in Falls Church, Virginia.

Sponsor
Inova Health Care Services
Study ID
NCT05710315
Status
Recruiting
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Conditions

  • Exocrine Pancreatic Insufficiency
  • Multi Organ Failure

Eligibility Criteria

Sex
ALL
Age
18 Years - 89 Years
Healthy Volunteers
Not accepted

Interventions

  • RELiZORB™ — DEVICE
    RELiZORB cartridges will be used with routine enteral feedings for 5 days for randomized participants
  • Placebo — OTHER
    Placebo cartridges will be used with routine enteral feedings for 5 days for randomized participants

Study Details

The purpose of this research is to determine if the use of RELiZORB™ improves nutrition tolerance and helps critically ill patients meet their nutrition goals. RELiZORB™ is a digestive enzyme cartridge that contains lipase and works as a pancreatic enzyme replacement. It promotes breaking down fat and helps the body absorb it. The device connects with tube feedings to help the body with digestion. RELiZORB™ is approved by the U.S. Food and Drug Administration (FDA) for use with tube feedings in patients 5 years of age or older. While the use of RELiZORB™ in this study is consistent with the FDA approval, the use of RELiZORB™ in patients with multi organ failure is not in the current standard of care practice at Inova Health Care facilities.

Key Dates

Start date
May 7, 2025
Status verified
Feb 2026
Primary completion
May 31, 2026
Completion
May 31, 2026

Study Design

Enrollment
32 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: RELiZORB
    RELiZORB™ cartridges connect in-line with existing enteral feeding pump tubing sets and patient extension sets or enteral feeding tubes.
  • Placebo Comparator: Placebo
    Placebo cartridges connect in-line with existing enteral feeding pump tubing sets and patient extension sets or enteral feeding tubes

Primary Outcome Measure

Efficacy of RELiZORB™ in Enteral Nutrition Tolerance in Critically Ill Adults with Multiple Organ Failure Over Five Days [ Time Frame: Duration of intervention (5 days) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Inova Fairfax Medical CampusFalls ChurchVirginia22042
Laura E Madarasz, MS,BA
[email protected]
703-776-2189
George J Kasotakis (PRINCIPAL_INVESTIGATOR)

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By research site
Inova Fairfax Medical Campus· Falls Church, VA

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